RA Executive – Diagnostics

Arni Medica Pvt Ltd.; Hinoba-an; On-site; PHP 591,000 - 789,000; Full time

Benefits offered by this job

Competitive compensation

Career growth opportunities

Job summary

Arni Medica Private Limited in Hyderabad, India is seeking a Regulatory Affairs Executive for diagnostics products to ensure timely registrations and compliance across domestic and export markets. You will prepare dossiers, manage CDSCO submissions via SUGAM, maintain DMFs and respond to authority queries, coordinating with R&D, QA, manufacturing and commercial teams.

The role requires 2–5 years in RA for diagnostics or medical devices, with a driving focus on ISO 13485, EU IVDR and FDA

Qualifications

• Education: B.Pharm / M.Pharm, M.Sc / B.Sc (Life Sciences, Biotech, Microbiology) or B.Tech; RA PG diploma a plus.
• Experience: 2–5 years of RA experience in diagnostics or medical devices.

Responsibilities

• Prepare and review regulatory dossiers and technical files for India (CDSCO) and export markets.
• File and track applications via the CDSCO SUGAM portal — MD-05/MD-09 (manufacturing) and MD-13/MD-14/MD-15 (import) as applicable.
• Maintain Device Master Files (DMF), submission trackers and regulatory correspondence.
• Coordinate responses to authority queries and submission deficiencies.
• Review labels, IFUs and product claims for compliance; issue / coordinate Free Sale Certificates (CFS) for exports.
• Monitor regulatory changes (CDSCO MDR 2017, ISO 13485, ISO 14971, EU IVDR, FDA) and assess business impact.

Skills

Regulatory affairs

Diagnostics/medical devices RA

Documentation & dossier prep

Education

B.Pharm / M.Pharm

M.Sc / B.Sc (Life Sciences, Biotech, Microbiology)

B.Tech

RA PG diploma

Tools

CDSCO SUGAM portal

MD-05/MD-09/MD-13/MD-14/MD-15

ISO 13485

EU IVDR

FDA 21 CFR Part 11

Job description

Patancheru, India | Posted on 08/27/2026

Job Title: Regulatory Affairs Executive – Diagnostics
Location: Hyderabad, India
Department: Regulatory Affairs
Experience: 2–5 years (RA in diagnostics or medical devices; freshers considered for junior roles)
Employment Type: Full-time, on-site

About Arni Medica

Arni Medica Private Limited is an ISO 13485:2016 and ISO 9001:2015 certified medical device and in-vitro diagnostics (IVD) manufacturer based at the Medical Devices Park, Sangareddy (Hyderabad), Telangana. We design and manufacture nephrology, infusion therapy, respiratory care and surgical disposables, and are building a full IVD diagnostics franchise spanning clinical chemistry, electrolyte/ISE, blood gas (ABG), fluorescence immunoassay (FIA) and chemiluminescence immunoassay (CLIA) platforms — backed by Class 100K/10K cleanrooms, EtO sterilization and a CDSCO manufacturing licence (MFG/MD/2023/000942).

Role Overview

The RA Executive will support product registrations, dossier preparation, technical documentation and ongoing regulatory compliance for diagnostics products in domestic and export markets, coordinating with R&D, QA, manufacturing and commercial teams to maintain timely submissions.

Key Responsibilities

• Prepare and review regulatory dossiers and technical files for India (CDSCO) and export markets.
• File and track applications via the CDSCO SUGAM portal — MD-05/MD-09 (manufacturing) and MD-13/MD-14/MD-15 (import) as applicable.
• Maintain Device Master Files (DMF), submission trackers and regulatory correspondence.
• Coordinate responses to authority queries and submission deficiencies.
• Review labels, IFUs and product claims for compliance; issue / coordinate Free Sale Certificates (CFS) for exports.
• Monitor regulatory changes (CDSCO MDR 2017, ISO 13485, ISO 14971, EU IVDR, FDA) and assess business impact.

Desired Candidate Profile

• Education: B.Pharm / M.Pharm, M.Sc / B.Sc (Life Sciences, Biotech, Microbiology) or B.Tech; RA PG diploma a plus.
• Experience: 2–5 years of RA experience in diagnostics or medical devices.

Technical Skills & Keywords

CDSCO, SUGAM portal, Medical Device Rules 2017 (MDR 2017), MD-05 / MD-09 / MD-13 / MD-14 / MD-15, ISO 13485:2016, ISO 14971, technical file / DMF / DHF, IVD registration, labelling & IFU compliance, Free Sale Certificate (CFS), post-market surveillance, 21 CFR Part 11 / FDA, EU IVDR / CE awareness.

Preferred / Good to Have

• Export-dossier and country-specific registration experience.
• IVD-specific (vs general device) regulatory experience.
• ISO 14971 risk-file and regulatory-intelligence tool exposure.

What We Offer

• A rare opportunity to help build a greenfield IVD diagnostics business from the ground up.
• Modern, ISO 13485 / CDSCO-compliant manufacturing environment with cleanroom infrastructure.
• Direct collaboration with R&D, Regulatory and senior leadership — visible impact, fast decisions.
• Competitive compensation, commensurate with experience (negotiable; as per industry standards).
• Accelerated career growth in a fast-scaling, export-oriented MedTech company.